Clinical Medical Monitoring Services

Our medical Monitors provide medical review and management of clinical trial activities for our clients. Our Monitors have extensive training and experience across a wide range of therapeutic areas and technological platforms. Our Monitors can work independently or become fully embedded in the client teams. They are often involved in preparing for first-in-man trials, and can bridge all phases of clinical trials.

Clinical Medical Monitoring Core Services:

  • Product Development planning
  • Document design, review and sign off from a medical point of view (Investigator Brochure, Protocol, CRF, Informed Consent, Study Manual, Statistical Analyses Plan, Data validation Plan, Study Reports, SAE narratives)
  • Study decisions regarding in/exclusion deviations, dosing questions, concomitant medication requests, emergencies (including 24/7 coverage)
  • Listing review of study data (demographics, physical exams, vitals, dosing, labs, EKG, concomitant medications, adverse events, efficacy parameters, protocol deviations) and cross referencing critical data fields for consistency
  • Coding review
  • Trend analyses for safety parameters during the trial
  • Data clarification
  • SAE narrative writing and submissions to regulatory
  • SAE reconciliation and coding
  • Literature evaluations (scientific, efficacy, safety and competitive analyses)